Antibióticos locales para implantes mamarios (BREAST-AB)
Tratamiento profiláctico de implantes mamarios con una solución de antibióticos de gentamicina, vancomicina y cefazolina para mujeres que se someten a cirugía reconstructiva mamaria: un ensayo controlado aleatorio (ensayo BREAST-AB)
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The BREAST-AB Trial will include women undergoing breast reconstruction with implants. The objective is to determine the efficacy of local antibiotics in decreasing all-cause implant explantation. Participants will be randomized to local application of placebo or gentamicin, vancomycin and cefazolin in a saline solution onto the implant and the dissected breast pocket. All patients undergoing unilateral breast reconstruction will be randomized to the trial drug or placebo in a ratio of 1:1. All patients undergoing bilateral reconstruction will be randomized to the trial treatment on one of their breasts and placebo to the contralateral breast. A total number of 1274 of breasts undergoing breast reconstruction will be included in the trial.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Aalborg, Dinamarca, 9000
- Aalborg University Hospital
-
Aarhus, Dinamarca, 8000
- Aarhus University Hospital
-
Copenhagen, Dinamarca, 2100
- Rigshospitalet
-
Esbjerg, Dinamarca, 6700
- South-West Jutland Hospital
-
Herlev, Dinamarca, 2730
- Herlev and Gentofte Hospital
-
Odense, Dinamarca, 5000
- Odense University Hospital
-
Roskilde, Dinamarca, 4000
- Zealand University Hospital
-
Vejle, Dinamarca, 7100
- Vejle Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
-
Age ≥ 18 years
-
Biologically female
-
Signed informed consent
-
Scheduled for breast reconstruction with implants or expanders including:
- Immediate or delayed reconstructions
- Bilateral or unilateral reconstructions
- With or without simultaneous flap reconstruction
Exclusion Criteria:
- Pregnancy
- Breast feeding
- Known allergy towards Vancomycin, Gentamicin and Cefazolin
- Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
- Known allergy towards neomycin
- Known impaired renal function with GFR < 60 mL/min
- Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
- Myasthenia Gravis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Irrigation of implants with sterile isotonic saline
The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag. |
500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
Otros nombres:
|
|
Experimental: Irrigation of implants with a triple antibiotic solution
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline |
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
All-cause explantation of the breast implant after the breast reconstruction surgery
Periodo de tiempo: 180 days
|
All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation. |
180 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to explantation (days)
Periodo de tiempo: 180 days
|
Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery. |
180 days
|
|
Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)
Periodo de tiempo: 180 days
|
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment |
180 days
|
|
Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)
Periodo de tiempo: 180 days
|
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment |
180 days
|
|
Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery
Periodo de tiempo: 180 days
|
Surgical site infection will be defined according to the CDC classification of surgical site infetion leading to antibiotic treatment with oral or intravenous antibiotics administered after the surgery. |
180 days
|
|
All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery
Periodo de tiempo: 1 year
|
All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation. |
1 year
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time from the breast reconstruction surgery to discharge (days)
Periodo de tiempo: 180 days
|
Time to discharge will be defined as the amount of days between the breast reconstruction and the day of discharge. |
180 days
|
|
Re-admission after the breast reconstruction surgery (Y/N)
Periodo de tiempo: 180 days
|
The breast reconstruction surgery will be defined as the surgery where the patient received the allocated treatment. |
180 days
|
|
Long term follow-up after 5, 10 and 15 years
Periodo de tiempo: 15 years
|
Capsular contracture and the Baker classification grade will be obtained from the National Patient Registry and the patients' medical journals after 5, 10 and 15 years. The BREAST-Q questionnaire will be used to assess patient-reported outcomes. The patients will be contacted and asked to fill out the questionnaire with 5 year-intervals after the surgery. |
15 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mikkel Herly, MD, Ph.D., Department of Plastic Surgery and Burns Treatment
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Complicaciones Postoperatorias
- Procesos Patológicos
- Inflamación
- Condiciones Patológicas, Signos y Síntomas
- Reacción de cuerpo extraño
- Fracaso de la prótesis
- Contractura capsular del implante
- Péptidos
- Aminoácidos, péptidos y proteínas
- Compuestos de azufre
- Químicos orgánicos
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Carbohidratos
- Glucósidos
- Amidas
- Aminoglucósidos
- Glucoconjugados
- beta-lactamas
- Lactamas
- Cefalosporinas
- Tiazinas
- Glucopéptidos
- Vancomicina
- Cefazolina
- Gentamicinas
Otros números de identificación del estudio
- BREAST-AB-01
- 2020-002459-40 (Número EudraCT)
- 0058322 (Otro número de subvención/financiamiento: Novo Nordisk Foundation)
- R-189- A4127 (Otro número de subvención/financiamiento: Medicine Fund of the Danish Regions)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The protocol including the statistical analysis plan is published in BMJ Open (doi:10.1136/bmjopen-2021-058697) prior to unblinding. The main article will include the primary and secondary outcomes. The tertiary and long-term outcomes will be included in subsequent articles. The manuscripts will be submitted to peer-reviewed international journals and both positive, negative and inconclusive results will be published. The findings of the trial will be shared with participating sites and presented at national and international conferences. The results will be disseminated to the public but will not be shared directly with participating patients.
Marco de tiempo para compartir IPD
After the end of the trial, the data will become available (Anticipated july 2025)
Criterios de acceso compartido de IPD
Researchers and other relevant parties can be granted access to selected anonymized data after publication upon request to the principal-sponsor investigator
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .